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Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength and Mobilization in Healthy Volunteers

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT01449097
Collaborator
(none)
12
Enrollment
1
Location
3
Arms
1
Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the femoral nerve block versus placebo on muscle strength in healthy volunteers. The investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of the quadriceps muscle strength compared to the femoral nerve block.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Adductor-Canal-Blockade
  • Procedure: The femoral nerve block
  • Procedure: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of the Efficacy of the Adductor-Canal-Blockade Versus the Femoral Nerve Block on Muscle Strength and Mobilization in Healthy Volunteers: a Randomized Study
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adductor-Canal-Blockade

Procedure: Adductor-Canal-Blockade
US-guided Adductor-Canal-blockade with Ropivacaine
Active Comparator: The femoral nerve block

Procedure: The femoral nerve block
US-guided femoral nerve block with ropivacaine
Placebo Comparator: Placebo

Procedure: Placebo
US-guided Adductor-Canal-Blockade/femoral nerve block with saline

Outcome Measures

Primary Outcome Measures

  1. the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo [0-6 hours]

Secondary Outcome Measures

  1. The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block [0-6 hours]

  2. The difference in quadriceps muscle strength between the placebo and the femoral nerve block [0-6 hours]

  3. The difference in adductor muscle strength between the groups [0-6 hours]

  4. The difference in mobilization between the groups [0-6 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • written informed consent

  • ASA 1

  • BMI > 18 og < 25

Exclusion Criteria:

  • Can not cooperate to the exam

  • Do not speak or understand Danish

  • Drug allergy

  • Alcohol or drug abuse

  • Daily consumption of analgetics on prescription

  • Any drug intake within the last 48 hours

  • Neuromuscular defects in the femoral nere, the obturator nerve or the muscles of the thigh.

  • Previous surgery or trauma to the lower limb

  • Diabetes Mellitus

  • Intake of steroids, except steroids for inhalation

  • Physical exercise within the last 24 hours prior to Day 1 and 2 of the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark 2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Pia Jæger, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pia Jaeger, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01449097
Other Study ID Numbers:
  • SM2-PJ-11
First Posted:
Oct 7, 2011
Last Update Posted:
Dec 22, 2011
Last Verified:
Dec 1, 2011
Keywords provided by Pia Jaeger, Principal investigator, Rigshospitalet, Denmark
Adductor-Canal-blockade,
human volunteers,
US-guided nerve block
femoral nerve block

Study Results

No Results Posted as of Dec 22, 2011